[Congressional Record Volume 170, Number 143 (Monday, September 16, 2024)]
[Senate]
[Page S6058]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3280. Mr. PETERS (for himself, Mr. Lankford, and Mr. Braun) 
submitted an amendment intended to be proposed by him to the bill S. 
4638, to authorize appropriations for fiscal year 2025 for military 
activities of the Department of Defense, for military construction, and 
for defense activities of the Department of Energy, to prescribe 
military personnel strengths for such fiscal year, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of subtitle H of title X, insert the following:

     SEC. 10___. U.S. PHARMACEUTICAL SUPPLY CHAINS MAPPING.

       (a) Short Title.--This section may be cited as the 
     ``Mapping America's Pharmaceutical Supply Act'' or the ``MAPS 
     Act''.
       (b) Pharmaceutical Supply Chain Mapping.--The Secretary of 
     Health and Human Services (referred to in this section as the 
     ``Secretary''), in coordination with the heads of other 
     relevant Federal departments and agencies, shall ensure 
     coordination of efforts of the Department of Health and Human 
     Services, including through public-private partnerships, to--
       (1) map, or otherwise visualize, the supply chains, from 
     manufacturing of key starting materials through manufacturing 
     of finished dosage forms and distribution, of drugs (as 
     defined in section 201 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321)) that are--
       (A) directly related to responding to chemical, biological, 
     radiological, or nuclear threats and incidents covered by the 
     National Response Framework; or
       (B) of greatest priority for providing health care and 
     identified as being at high risk of shortage; and
       (2) use data analytics to identify supply chain 
     vulnerabilities that pose a threat to national security, as 
     determined by the Secretary or the heads of other relevant 
     Federal departments and agencies.
       (c) Requirements.--In carrying out subsection (b), the 
     Secretary shall--
       (1) describe the roles and responsibilities of agencies and 
     offices within the Department of Health and Human Services 
     related to monitoring such supply chains and assessing any 
     related vulnerabilities;
       (2) facilitate the exchange of information between Federal 
     departments, agencies, and offices, as appropriate and 
     necessary to enable such agencies and offices to carry out 
     roles and responsibilities described in paragraph (1) related 
     to drugs described in subsection (b)(1), which may include--
       (A) the location of establishments registered under 
     subsection (b), (c), or (i) of section 510 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360) involved in the 
     production of active pharmaceutical ingredients and finished 
     dosage forms of drugs described in subsection (b)(1), and the 
     amount of such ingredients and finished dosage forms produced 
     at each such establishment;
       (B) to the extent available and as appropriate, the 
     location of establishments so registered involved in the 
     production of the key starting materials and excipients 
     needed to produce the active pharmaceutical ingredients and 
     finished dosage forms, and the amount of such materials and 
     excipients produced at each such establishment; and
       (C) any regulatory actions with respect to such drugs or 
     the establishments manufacturing such drugs, including with 
     respect to inspections and related regulatory activities 
     conducted under section 704 of such Act (21 U.S.C. 374), the 
     seizure of such a drug pursuant to section 304 of such Act 
     (21 U.S.C. 334), any recalls of such a drug; inclusion of 
     such a drug on the drug shortage list under section 506E of 
     such Act (21 U.S.C. 356e), or prior drug shortages reports of 
     a discontinuance or interruption in the production of such a 
     drug under 506C of such Act (21 U.S.C. 355d).
       (d) Report.--Not later than 18 months after the date of 
     enactment of this Act, and annually thereafter, the 
     Secretary, in consultation with the heads of agencies with 
     which the Secretary coordinates under subsection (b), shall 
     submit a report to the relevant committees of Congress on--
       (1) the current status of efforts to map and analyze 
     pharmaceutical supply chains, as described in subsection (b);
       (2) activities of the Secretary carried out under this 
     section to coordinate efforts as described in subsection (b), 
     including information sharing between relevant Federal 
     departments, agencies, and offices;
       (3) the roles and responsibilities described in subsection 
     (c)(1), including the identification of any gaps, data 
     limitations, or areas of unnecessary duplication between such 
     roles and responsibilities;
       (4) the extent to which Federal agencies use data analytics 
     to conduct predictive modeling of anticipated drug shortages 
     or risks associated with supply chain vulnerabilities that 
     pose a threat to national security; and
       (5) the extent to which the Secretary has engaged relevant 
     industry in such mapping.
       (e) Confidential Commercial Information.--The exchange of 
     information among the Secretary and the heads of other 
     relevant Federal departments and agencies, for purposes of 
     carrying out this section shall not be a violation of section 
     1905 of title 18, United States Code. This section shall not 
     be construed to affect the status, if any, of such 
     information as trade secret or confidential commercial 
     information for purposes of section 301(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), section 552 
     of title 5, United States Code, or section 1905 of title 18, 
     United States Code.
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